U.S. patent number 5,503,635 [Application Number 08/151,614] was granted by the patent office on 1996-04-02 for apparatus and method for performing compressional anastomoses.
This patent grant is currently assigned to United States Surgical Corporation. Invention is credited to Roger J. Greenwald, John F. Hammond, Jude S. Sauer, Jeffrey M. Shaw, Theodore J. Tiberio.
United States Patent |
5,503,635 |
Sauer , et al. |
April 2, 1996 |
Apparatus and method for performing compressional anastomoses
Abstract
Apparatus and method for forming a compression anastomosis of a
hollow organ. The apparatus comprising a first collapsible member
movable between an expanded configuration and a collapsed
configuration, the first collapsible member having a longitudinal
bore defined by an inner surface, a first mating member, locking
structure disposed on the first collapsible member for locking the
first collapsible member with the first mating member, a second
collapsible member movable between an expanded configuration and a
collapsed configuration, the second collapsible member having a
longitudinal bore defined by an inner surface, a second mating
member, locking structure disposed on the second collapsible member
for locking the second collapsible member with the second mating
member, and the first member adapted to interlock with the second
member. A tissue retaining device is also provided which comprises
a mating member having a receiving portion formed thereon, said
receiving portion having an inner surface and securing structure
comprising a ring having an outer surface dimensioned and
configured for insertion into said receiving surface to compress
tissue between said outer surface of said ring and an inner surface
of said mating member receiving portion.
Inventors: |
Sauer; Jude S. (Pittsford,
NY), Greenwald; Roger J. (Holley, NY), Tiberio; Theodore
J. (Hilton, NY), Shaw; Jeffrey M. (Livonia, NY),
Hammond; John F. (Canandaigua, NY) |
Assignee: |
United States Surgical
Corporation (Norwalk, CT)
|
Family
ID: |
22539525 |
Appl.
No.: |
08/151,614 |
Filed: |
November 12, 1993 |
Current U.S.
Class: |
606/153; 606/151;
606/154 |
Current CPC
Class: |
A61B
17/1114 (20130101); A61B 17/11 (20130101); A61B
2017/1135 (20130101); A61B 2017/1139 (20130101) |
Current International
Class: |
A61B
17/11 (20060101); A61B 17/03 (20060101); A61B
017/00 () |
Field of
Search: |
;606/151,153,154,150
;623/1,11,12 ;128/899 |
References Cited
[Referenced By]
U.S. Patent Documents
Foreign Patent Documents
|
|
|
|
|
|
|
0517488 |
|
Dec 1992 |
|
EP |
|
1537228 |
|
Jan 1990 |
|
SU |
|
WO93/20757 |
|
Oct 1993 |
|
WO |
|
Other References
Rebuffat et al., Clinical Application of a New Compression
Anastomotic Device for Colorectal Surgery, The American Journal of
Surgery, vol. 159, pp. 330-335, Mar. 1990. .
Rosati et al., A New Mechanical Device for Circular Compression
Anastomosis, Ann. Surg., vol. 207, No. 3, pp. 245-253, Mar.
1988..
|
Primary Examiner: Pellegrino; Stephen C.
Assistant Examiner: Schmidt; Jeffrey A.
Claims
What is claimed is:
1. A compression device for the anastomosis of a hollow organ,
comprising:
(a) a first collapsible member movable between an expanded
configuration and a collapsed configuration;
(b) a first tissue retaining member insertable in said first
collapsible member to maintain said first collapsible member in
said expanded configuration and hold tissue between said first
tissue retaining member and said first collapsible member;
(c) a second collapsible member movable between an expanded
configuration and a collapsed configuration; and
(d) a second tissue retaining member insertable in said second
collapsible member to hold tissue between said second tissue
retaining member and said second collapsible member; wherein said
first and second collapsible members are configured and dimensioned
to interlock with each other.
2. A compression device for the anastomosis of a hollow organ,
comprising:
(a) a first collapsible member movable between an expanded
configuration and a collapsed configuration, said first collapsible
member having a longitudinal bore defined by an inner surface;
(b) a first mating member configured and dimensioned to maintain
said first collapsible member in said expanded configuration;
(c) locking means disposed on said first collapsible member for
locking said first collapsible member with said first mating
member;
(d) a second collapsible member movable between an expanded
configuration and a collapsed configuration, said second
collapsible member having a longitudinal bore defined by an inner
surface;
(e) a second mating member;
(f) locking means disposed on said second collapsible member for
locking said second collapsible member with said second mating
member; and
(g) said first mating member being configured and dimensioned to
interlock with said second mating member.
3. A compression device for the anastomosis of hollow organs
according to claim 2, wherein said first and second collapsible
members are configured and dimensioned such that they are
insertable in a trocar cannula when said first and second
collapsible members are in said collapsed configurations.
4. A compression device for the anastomosis of hollow organs
according to claim 3, wherein said first collapsible member
comprises an annular base having finger members extending from said
annular base, said annular base having the same shape in the
expanded and collapsed configuration.
5. A compression device for the anastomosis of hollow organs
according to claim 3, wherein said second collapsible member
comprises an annular base having finger members extending from said
annular base, said annular base having the same shape in the
expanded and collapsed configurations.
6. A compression device for the anastomosis of hollow organs
according to claim 2, wherein at least one of said first and said
second collapsible members includes a plurality of adjacent finger
members.
7. A compression device for the anastomosis of hollow organs
according to claim 4, wherein at least some of said finger members
are permanently joined together in a predetermined spatial
relationship.
8. A compression device for the anastomosis of hollow organs
according to claim 6, further comprising clamping means associated
with said finger members, for clamping said finger members
together.
9. A compression device for the anastomosis of hollow organs
according to claim 8, wherein said clamping means includes an
annular ring configured and dimensioned to hold said finger members
together.
10. A compression device for the anastomosis of hollow organs
according to claim 2, wherein said first mating member includes an
axle member having latching means disposed thereon for interlocking
with said locking means.
11. A compression device for the anastomosis of hollow organs
according to claim 2, wherein said second mating member includes an
axle member having latching means disposed thereon for interlocking
with said locking means.
12. A compression device for the anastomosis of hollow organs
according to claim 2, wherein at least one of said collapsible
members is made from partially bioabsorbable materials.
13. A compression device for the anastomosis of hollow organs
according to claim 2, wherein at least one of said collapsible
members is made from totally bioabsorbable materials.
14. A compression device for the anastomosis of hollow organs
according to claim 2, wherein said first collapsible member
includes holding means disposed thereon, for holding said
collapsible member in a collapsed position and said second
collapsible member includes holding means disposed thereon, for
holding said collapsible member in a collapsed position.
15. A compression device for the anastomosis of hollow organs
according to claim 2, further comprising a tissue retaining member
adapted for insertion into said first collapsible member, thereby
exerting an outwardly directed force on an inside perimeter of said
first collapsible member when tissue of said hollow organ is locked
between said tissue retaining member and said inside perimeter of
said first collapsible member.
16. A compression device for the anastomosis of hollow organs
according to claim 15, wherein said tissue retaining member
includes an annular ring.
17. A compression device for the anastomosis of hollow organs
according to claim 2, further comprising a tissue retaining member
adapted for insertion into said second collapsible member, thereby
exerting an outwardly directed force on an inside perimeter of said
second collapsible member when tissue of said hollow organ is
locked between said tissue retaining member and said inside
perimeter of said second collapsible member.
18. A compression device for the anastomosis of hollow organs
according to claim 17, wherein said tissue retaining member
includes an annular ring.
19. A tissue retaining device comprising:
(a) a mating member including at least two segmented portions and a
receiving portion formed thereon, said receiving portion having an
inner surface; and
(b) means for securing tissue to said mating member, said securing
means comprising a ring having an outer surface dimensioned and
configured for insertion into said receiving portion to compress
tissue between said outer surface of said ring and said inner
surface of said mating member receiving portion; whereby said at
least two segmented portions are radially collapsible prior to
insertion of said securing means into said receiving portion.
20. A tissue retaining device, according to claim 19 wherein said
ring is circular.
21. A tissue retaining device, according to claim 19 wherein said
ring has a uniform diameter.
Description
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates to apparatus and method for
performing circular end-to-end compression anastomoses and more
particularly, to apparatus and method for performing compression
anastomoses endoscopically.
2. Description of the Related Art
Performing anastomoses to connect tissue within the body is
well-known in the art. For example, circular end-to-end anastomoses
are commonly performed to join together the ends of hollow organs
such as the intestines. Typically, a diseased or blocked portion of
the intestine is cut-out and the healthy ends joined together. One
method of performing anastomoses involves the use of compression
members which compress the ends of the hollow sections to be joined
together, thereby allowing a natural anastomosis to occur in the
tissue adjacent the compressed tissue. After a period of time, due
to necrosis of the compressed edges, the compression devices fall
inside the intestine and are then evacuated therefrom during normal
excretion of waste. Compression anastomoses have typically been
performed by gaining access to the surgical site either rectally or
through open surgery. In the case of the rectally performed
procedures, anastomosis is limited to the most distal tracts of the
intestine. In the case of open surgery to place compression
members, the patient's recovery is lengthened due to the extensive
healing required of the incisions made to access the surgical
site.
Another method of performing anastomoses involves the use of a
circular stapling device which applies an annular array of staples
to join the ends of hollow organs. A common procedural step of
forming an anastomosis, either using a circular stapler or with
other known methods and apparatus, is to apply a "purse string"
suture to each of the ends to be anastomosed. The "purse string"
suture is utilized to draw the ends of the hollow organ closed so
that, inter alia, a complete anastomosis is formed when the ends of
the organ are joined either by compression devices or by a surgical
stapling device.
In laparoscopic procedures, surgery is performed in the interior of
the abdomen through small incisions; in endoscopic procedures,
surgery is performed in any hollow viscus of the body through
narrow endoscopic tubes inserted through natural orifices.
Laparoscopic procedures generally require that any instrumentation
inserted into the body be sealed, i.e. provisions must be made to
ensure that gases do not enter or exit the body through the
laparoscopic incision or instruments as, for example, in surgical
procedures in which the surgical region is insufflated. Moreover,
laparoscopic and endoscopic procedures often require the surgeon to
act on organs, tissues and vessels deep within the body, thereby
requiring that any instruments be used in such procedures be long
and narrow while being functionally controllable from the end of
the instrument outside the patient's body, i.e. the proximal end.
Typically, in laparoscopic and endoscopic procedures, patient
recovery time is several days or weeks shorter than that for
conventional invasive surgical procedures.
A need presently exists for apparatus and methods which facilitate
performing anastomoses through small incisions using compression
anastomosis devices which fit through cannulas of lesser diameter
than the hollow organ to be anastomosed. That is, a need presently
exists for apparatus and methods capable of performing
compressional anastomoses endoscopically or laparoscopically so as
to both increase the versatility of the procedure and reduce
patient recovery time.
An additional need exists for alternative apparatus and method
which will perform the function performed by "purse stringing" the
ends of hollow organs to be anastomosed.
SUMMARY OF THE INVENTION
The present invention provides novel apparatus and method for
compression anastomoses. A compression device is provided for the
anastomosis of a hollow organ and includes a first collapsible
member movable between an expanded configuration and a collapsed
configuration, the first collapsible member having a longitudinal
bore defined by an inner surface; a first mating member; locking
means disposed on the first collapsible member for locking the
first collapsible member with the first mating member; a second
collapsible member movable between an expanded configuration and a
collapsed configuration, the second collapsible member having a
longitudinal bore defined by an inner surface; a second mating
member; locking means disposed on the second collapsible member for
locking the second collapsible member with the second mating
member; and the first member adapted to interlock with the second
member; whereby when the first and second collapsible members are
in the collapsed configurations, the collapsible members are
configured and dimensioned such that they are insertable in a
cannula for placement in the open ends of a hollow organ.
Preferably, at least one of the first and the second collapsible
members includes a plurality of adjacent finger members. In an
alternate embodiment, at least some of the finger members are
permanently joined together in a predetermined spatial
relationship. The device may further comprise clamping means
associated with the finger members, for clamping the finger members
together. The clamping means preferably includes an annular ring
configured and dimensioned to hold the finger members together.
In one embodiment, either the first or the second mating members
includes an axle member having latching means disposed thereon for
interlocking with the locking means. Preferably, at least one of
the collapsible members is made from either partially or totally
bioabsorbable or biofragmentable materials.
Holding means are provided on the first and second collapsible
members for holding the collapsible members in a collapsed
position. Additionally, a tissue retaining member adapted for
insertion into either or both, the first and second collapsible
members, thereby exerting an outwardly directed force on an inside
perimeter of the first collapsible member when tissue of the hollow
organ is locked between the tissue retaining member and the inside
perimeter of the first collapsible member. The tissue retaining
member is preferably an annular ring.
In one embodiment, the first and/or the second collapsible members
comprise an annular base having finger members extending from the
annular base, the annular base having the same shape in the
expanded and collapsed configuration.
A surgical instrument for carrying and attaching separate
components of a compression anastomosis device to the end of tissue
of a hollow organ, is provided which includes an elongated housing
having a proximal end and a distal end; supporting means
operatively associated with the distal end of the elongated
housing, for supporting and aligning a plurality of compression
anastomosis device components; assembling means associated with the
supporting means, for assembling at least two of the compression
anastomosis device components; actuating means operatively
connected to the proximal end of the elongated housing, for
selectively actuating the assembling means such that the assembling
means travels a predetermined distance in a first direction and
then travels a predetermined distance in a second direction; and
driving means associated with the distal end of the elongated
housing, for driving at least one of said compression anastomosis
device components such that said separate components become
attached to the end of said hollow organ.
In an alternate embodiment, cutting means are provided and are
operatively mounted at the distal end of the elongated housing
means, for selectively cutting away excess tissue.
The supporting means may include at least one retaining portion for
releasably retaining at least one of the compression anastomosis
device components. The retaining portion may include at least one
expandable member movable between a holding position and a released
position, the expandable member being configured and dimensioned to
releasably retain at least one of the compression anastomosis
device components. The at least one expandable member preferably
includes a plurality of radially expandable elements. Release
control means, operable from the proximal end of the elongated
housing, for controlling the at least one expandable member between
the holding position and the released position are also preferably
provided.
The present invention further provides a surgical device for
approximating surgical implant device components inserted within a
cavity of a body. The device includes an elongated housing; and at
least two grasping means operatively attached to the elongated
housing, each of the grasping means being operable between an open
position and a closed position, for receiving and grasping surgical
implant device components; whereby at least one of the at least two
grasping means are further movable toward and away from the other
of the at least two grasping means, between a first position for
receiving the surgical implant device components and a second
position for joining the surgical implant device components.
The approximating device may further comprise positioning means
operatively associated with each of the at least two grasping means
for positioning the grasping means at a predetermined position
between the open and closed positions. Alternatively, each of the
at least two grasping means includes a pair of finger members
configured and dimensioned to releasably hold the surgical implant
device components. Closure controlling means may also be provided
which are operatively associated with each pair of finger members
for controlling the closure of each finger of the pair of finger
members such that closure of each of the finger members of the pair
of finger members travels a predetermined distance independent of
the other finger of the pair of fingers.
In one embodiment of the approximating device, actuating means are
operatively connected to the proximal end of the elongated housing
means for selectively actuating opening and closing of the grasping
means.
A method for forming a compression anastomosis is provided and
comprises the steps of providing a compression device for the
anastomosis of hollow organs, the device including at least two
collapsible components; providing a surgical instrument for
carrying and attaching the separate components of the compression
anastomosis device to the ends of hollow tissue sections; providing
a surgical device for approximating compression anastomosis device
components which includes elongated housing means; and at least two
grasping means operatively attached to the elongated housing
member, each of the grasping means being operable between an open
position and a closed position, for receiving and grasping
compression anastomosis device components; whereby at least one of
the at least two grasping means are further movable toward and away
from the other of the at least two grasping means, between a first
position for receiving the compression anastomosis device
components and a second position for joining the compression
anastomosis device components; inserting the first and second
collapsible members in open ends of hollow tissue sections to be
joined using the surgical instrument for carrying and attaching
separate components of a compression anastomosis device to the end
of a hollow tissue section; and approximating the inserted first
and second hollow tissue members using the device for approximating
compression anastomosis device components such that the first and
second collapsible members are interlocked together.
A novel tissue retaining device is also provided which is utilized
to replace the use of conventional "purse string" suturing. The
tissue retaining device includes a mating member having a receiving
portion formed thereon, said receiving portion having an inner
surface, and means for securing tissue to said mating member, said
securing means comprising a ring having an outer surface
dimensioned and configured for insertion into said receiving
surface to compress tissue between said outer surface of said ring
and an inner surface of said mating member receiving portion.
In one embodiment the ring is circular. Alternatively, the ring may
have a uniform diameter. The tissue retaining ring has several
advantages over conventional "purse string" suturing, for example,
the ring is readily applied using the same instrument used to
insert the other compression anastomosis device components.
Therefore, less instrumentation is required in the operating room
environment and less time is needed to prepare the tissue for the
anastomoses.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is an exploded perspective view of the component parts of
the stent ring, the inner stent fingers, the outer stent fingers,
the male and female axles and the snap ring;
FIG. 2A is an exploded perspective view of the stent collapser, the
stent finger assembly including the inner and outer fingers and the
collapsing ring;
FIG. 2B is a partially cut-away side view illustrating the stent
ring, inner stent fingers and outer stent fingers mounted together
in a collapsed position;
FIG. 3 is a vertical cross-section view of the top portions of the
inner and outer stent fingers with the fingers in a pre-collapsed
position;
FIG. 4 is a partially cut-away side view of the inner surfaces of
the inner and outer stent fingers in a collapsed position;
FIG. 5 is a cross-sectional view taken along line 5--5 of FIG.
4;
FIG. 6 is an overall perspective view of the stent applicator
instrument;
FIG. 7 is an exploded perspective view of the stent applicator
handle showing the various component parts separated;
FIG. 8 is a partial cross-sectional view taken along line 8--8 of
FIG. 6 of the left side of the handle portion in the normal
position ready for endoscopic deployment;
FIG. 9 is an exploded partial view of the stent release lockout
mechanism;
FIG. 10 is a fragmentary cross-sectional view taken along line 9--9
of FIG. 6;
FIG. 11 is a cross-sectional view along line 11--11 of FIG. 10;
FIG. 12 is an exploded perspective view of the endoscopic section
of the stent applicator with the various components separated;
FIG. 13 is a horizontal cross-sectional view of the distal end of
the stent applicator instrument which shows the stent arbor, the
axle holder and the cutter blade retracted within the body of the
instrument;
FIG. 14 is a partial perspective view of the distal end of the
stent applicator device with the cutter blade extended;
FIG. 15 is a cross-sectional view taken along lines 15--15 of FIG.
13;
FIG. 16 is a view similar to FIG. 8, but shows the rear trigger
depressed;
FIG. 17 is a view similar to FIG. 16, but shows the front trigger
depressed whereby the snap ring is inserted into the stent
assembly;
FIG. 18 is a horizontal cross-sectional view which shows the cutter
blade in position ready to cut away excess tissue from the
anastomotic site;
FIG. 19 is a cross-sectional view taken along the line 19--19 of
FIG. 18 which shows the rotation of the cutting blade through the
tissue;
FIG. 20 is a partial top plan view of the rear end of the handle
member which shows the stent release toggle in the raised
position;
FIG. 21 is a partial cross-sectional view taken along line 21--21
of FIG. 20 which shows part of the right-hand portion of the
handle;
FIG. 22 is a partial cross-sectional view taken along line 22--22
of FIG. 20 which shows part of the left-hand portion of the
handle;
FIG. 23 is a partial view which shows the stent arbor at the distal
end of the stent applicator instrument when the stent release
toggle is in the raised position;
FIGS. 24-26 show some of the steps of preparing the stent
applicator instrument for use;
FIG. 27 is an end plan view of the female axle of the stent
assembly;
FIG. 28 is a partial cross-sectional view showing the keying of the
stent axle to the axle holder on the stent applicator
instrument;
FIG. 29-31 are views which show steps, subsequent to those of FIGS.
24-26, in preparing the stent applicator instrument for use;
FIG. 32 is a partial end view of the distal end of the stent
applicator which shows a stent assembly locked onto the stent
arbor;
FIG. 33 and 34 are views which show steps, subsequent to those of
FIGS. 29-31, in preparing the stent applicator instrument for
use;
FIG. 35 is a partial plan view illustrating the triggers of the
stent applicator handle in their pre-fired state;
FIG. 36 is a partial view of the distal end of the instrument with
the elements positioned corresponding to the trigger positions of
FIG. 35;
FIG. 37 is a view similar to FIG. 35 with the rear trigger
depressed;
FIG. 38 is a view similar to FIG. 36, illustrating the expansion of
the stent assembly upon depression of the rear trigger as shown in
FIG. 37;
FIG. 39 is a view similar to FIGS. 35 and 37, which shows both the
rear and the forward triggers depressed;
FIG. 40 is a view similar to FIGS. 36 and 38, which shows the snap
ring being forced into the stent assembly by the forward trigger
depression as shown in FIG. 39;
FIG. 41 is a view similar to FIG. 39, which shows the stent release
toggle in the release position;
FIG. 42 is a view similar to FIG. 40, which shows the stent
assembly released from the stent arbor after the stent release
toggle is moved to the release position as shown in FIG. 41;
FIGS. 43-49 illustrate steps of attaching a stent assembly to one
side of a hollow organ to be joined during an anastomosis;
FIG. 50 illustrates the completed insertion of both male and female
stent portions in the ends of the hollow tissue;
FIGS. 51-54 illustrate preparation steps required before reusing
the instrument;
FIG. 55 is a perspective view of the stent assembly closure device
with a portion shown in phantom lines to illustrate a range of
movement of the wrist portion;
FIG. 56 is an exploded perspective view of the handle portion of
the closure device;
FIG. 57 is a view of the inside of the left side handle area of the
closure device with the right half-section of the handle cover
removed;
FIG. 58 is a partial cross-sectional view, which shows the mounting
of a finger push rod to a toggle;
FIG. 59 is an exploded perspective view of the wrist and the finger
mechanisms of the closure device;
FIG. 60 is a partial view of the right-side finger control lever
positioned so that the corresponding fingers are in the completely
open position;
FIG. 61 is a partial view of the right-side finger control lever
positioned so that the corresponding fingers are in the holding or
clamped position;
FIG. 62 is a partial cross-sectional view taken along line 62--62
of FIG. 61, which shows some of the details of the toggles and the
detent actions of the left and right toggles;
FIG. 63 is a diagrammatic view of the distal end of the stent
closing instrument, which shows one finger pair in a closed
position for insertion or removal in a cannula;
FIG. 64 is a diagrammatic view which shows the finger pair of FIG.
63 completely open corresponding to the toggle position in FIG.
60;
FIG. 65 is diagrammatic view which shows the finger pair of FIG. 63
in the clamped position, corresponding to the toggle position
showing in FIG. 61;
FIG. 66 is a partial view of the closure device handle portion with
the wrist lever in the forward position;
FIG. 67 is a partial cross-sectional view of the distal end of the
closing device, which shows the right gripping fingers shifted
outwardly by the wrist member when the wrist lever is moved
forward;
FIG. 68 is a perspective view of the distal end of the stent
closing device, which shows the fingers clamped about the two
sections of the organ to be joined;
FIG. 69 is a top plan view where the wrist is in a closed position;
and
FIG. 70 is an enlarged cross-sectional view taken along line 70--70
of FIG. 69 which shows the male and female axles coupled
together.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
I. GENERAL
In general, the overall objective of the method and apparatus is to
endoscopically place a collapsible anastomotic compressional stent
device to achieve an end-to-end (or end-to-side, or side-to-side)
anastomosis without resorting to open surgery or performing the
anastomosis by rectal access. The invention includes three main
parts: a collapsible stent assembly, a stent applicator instrument
and a stent assembly closing device. The following is a short
description of the parts of the stent assembly and the function or
overall operation of the instruments used to place and join the
stent.
Briefly, the collapsible stent assembly includes a number of
component parts. A stent finger assembly including either a male or
female axle member is assembled with a sub-assembly of inner stent
fingers and outer stent fingers to form a male stent portion or
female stent portion, respectively. The respective male and female
stent portions are attached, by the insertion of a novel snap-ring,
to the respective ends of a hollow organ to be joined. The
snap-ring is utilized in lieu of conventional "purse-string"
suturing which is typically applied to the end of each tissue
section to be joined.
In order to achieve the placement of the stent portions, a novel
applicator instrument has been developed which is inserted through
the appropriately sized trocar cannula. The applicator instrument
contains several mechanisms to effectively accomplish placement of
the stent portions on the ends of the hollow organ to be
anastomosed. As will be explained in detail, the applicator
instrument is loaded with a snap-ring, the desired axle, i.e. male
or female, and a collapsed stent finger assembly. The instrument is
configured so that when either axle member is situated thereon they
can be positioned to hold the stent finger assembly in the
collapsed state during insertion through the trocar cannula.
Once the instrument has been inserted through the trocar cannula,
one end of the hollow organ to be joined is pulled over the end of
the instrument. When the instrument is partially inserted in the
hollow organ, a unique mechanism is actuated which first causes the
axle member to move away from the stent finger assembly until the
axle is no longer engaging the stent finger assembly. Then in the
same continued depression of the appropriate trigger, the mechanism
causes the axle member to move toward the stent finger assembly
entering it and causing the stent fingers to expand to their
operational position. The axle member is configured to lock in
place on the stent finger assembly.
When the axle member is locked in place a vacuum supply is turned
on and the end of the tissue is pulled inwardly toward the central
shaft of the instrument. A second trigger is pulled which forces a
snap ring to pass over the tissue pulled toward vacuum holes on a
shaft of the instrument. The snap ring locks into the end of the
stent portion such that tissue is trapped between the snap ring and
the base of the stent finger assembly. The procedure is repeated
for the other end of the hollow organ to be anastomosed, except
that a mating axle, either male or female which ever was not used
for the first side, is used. When both male and female stent
portions have been placed, the mating portions of the respective
axle members are exposed on the end of the respective hollow
sections ready to be joined.
In order to join the respective ends of the hollow organ, a unique
closing device has been developed. The closing device includes two
pairs of gripping fingers. One pair is attached to a wrist
mechanism so that they can be moved toward and away from the other
pair. One end section of the hollow organ to be joined is grasped
between the first pair of fingers and the other end is grasped
between the second pair of fingers. A trigger is pulled which
activates a mechanism that closes the wrist and causes the pair of
fingers attached to the wrist to move toward the other pair of
fingers. The axle members mate and the anastomosis is complete.
The detailed description is divided into several sections to
describe the structure and the desired movements produced thereby
of the different apparatus of the present invention and a method
for using those apparatus. Those sections include the stent
assembly, stent assembly applicator and the stent assembly closing
device. Each of these sections will be further sub-divided into
sections describing the structure, operation and use of the various
components. Also a kit containing the necessary instrumentation for
performing an endoscopic placement of a collapsible anastomotic
compression device is described.
The various apparatus components will be described throughout the
following sections using the following numbering convention:
components forming part of the stent assembly will be designated by
reference numerals beginning with the number 200, components
forming part of the stent applicator will be labeled with reference
numerals beginning with 400 or 500 and components relating to the
stent closing device will be labeled with reference numerals
beginning with 600.
II. THE COLLAPSIBLE STENT ASSEMBLY
Referring initially to FIG. 1, the various components of a
compression device for the anastomosis of hollow organs such as a
collapsible stent assembly, for example, stent 200, are shown
therein in exploded perspective view. Stent 200 is particularly
adapted for endoscopic placement within an open end of a hollow
organ. Except where noted otherwise, the materials utilized in the
components of the collapsible stent generally include such
biocompatible materials as polypropylene or urethane. The various
components of the stent assembly may also be made from materials
which are either partially or totally bioabsorbable, e.g.
polylactide, polyglycolide, polydioxanone homopolymers, co-polymers
or blends thereof.
The different components which make up stent 200 include clamping
means, such as stent ring 210, inner stent finger member 212, outer
stent fingers 214, male axle 216 (or alternatively female axle 218)
and a tissue retaining member such as an annular ring or snap ring
220. To achieve an anastomosis, a first collapsible member or stent
half, e.g., male stent portion 221 (FIG. 50), is constructed using
male axle 216 in association with the remaining non-axle stent
components set forth above and is inserted in one side of the
hollow organ to be anastomosed. Another collapsible member or stent
half, e.g., female stent portion 223 (FIG. 50), is constructed
using female axle 218 in association with the remaining non-axle
stent components set forth above and is inserted into the other
hollow section to be anastomosed. The details of the procedures
involved in placing the stent half portions in the respective
hollow organ sections and then joining the stent-tissue complexes
together will be described in the following sections.
PREPARATION OF THE STENT FINGER SUB-ASSEMBLIES
FIGS. 2A-5 illustrate the pre-assembly steps and collapsing
procedure for forming a stent finger sub-assembly that can be
employed with either male or female stent portions 221 and 223,
respectively. The pre-assembly involves stent ring 210, inner stent
finger member 212 and outer stent fingers 214. As shown in phantom
lines in FIG. 1, outer stent fingers 214 are fitted on inner stent
finger member 212 between inner stent fingers 222, such that raised
portions 224 and channels 226 formed on the inner surface of lower
end portions 228 fit in groove 230 and around crown 232,
respectively. Once outer stent fingers 214 are in place around
inner stent finger member 212, clamping means, such as an annular
ring, for example, stent ring 210 is slid over crown 232 such that
tab portions 234 of stent ring 210 over crown 232 such that tab
portions 234 of stent ring 210 are aligned with inner fingers 222.
Outer stent fingers 214 are further held in place between inner
stent finger member 212 and stent ring 210 by means of rib portions
236 formed on the inner surface of stent ring 210, between tabs
234. Moreover, rib portions 236 are seated in channels 238 formed
on the outer surface of lower end portion 228 of outer stent
fingers 214.
The assembled stent fingers and stent ring are inserted in a
specially developed compressing device such as stent collapser 240
of FIG. 2A. Stent finger assembly 242 is placed in stent collapser
body 244 such that inner stent fingers 222 are aligned with stepped
partitions 246. Stent collapser ring 248 is placed over stent
collapser body 244 and stent finger assembly 242 such that posts
250 are aligned with cut-outs 252 and the top portion of outer
stent fingers 214. Stent collapser ring 248 is depressed, as shown
by FIG. 2B, so that posts 250 enter cut-outs 252 and force scent
finger assembly 242 downward so that step partitions 246 urge inner
stent fingers 222 inward.
The relationship of inner stent fingers 222 and outer stent fingers
214 is best shown in FIGS. 3-5. In the cross-sectional top view of
FIG. 3 the stent fingers are shown in a pre-collapsed state with
inner stent fingers 222 situated adjacent outer stent fingers 214
in an opposing fashion whereby extended portion 254 of outer stent
finger 214 is biased against extended portion 256 of inner stent
finger 222. Upon collapsing of stent finger assembly 242, as shown
in FIGS. 4 and 5, inner stent fingers 222 are urged inwardly by
step partitions 246, FIG. 2A, and outer fingers 214 are urged
closer to one another due to the reduced diameter of lower portion
258 of the inner surface of stent collapser body 244. Inner stent
fingers 222 enter behind holding means such as tabs 260 disposed
along the inner surface of outer stent fingers 214. Alternatively,
other holding means may be provided such as latching members or the
like. Stent finger assembly 242, now in a collapsed state and still
held in stent collapser body 244, is ready for insertion onto the
stent applicator device, described in the next section. This stent
finger assembly can be used with the male stent portion 221 or
female stent portion 223.
III. STENT APPLICATOR DEVICE
A. GENERAL
To place male stent portion 221 and female stent portion 223 in the
respective portions of hollow organs to be joined together to form
an anastomosis, a unique endoscopic instrument has been developed.
One embodiment of that instrument is illustrated in the perspective
view of FIG. 6 as stent applicator instrument 400. This section
will first describe the various components making up the handle
portion and endoscopic section of stent applicator instrument 400,
as illustrated in FIGS. 7-11 and 12-15, respectively. Next, a
description of the operation of the instrument's control elements
will be presented, as illustrated in FIGS. 16-23. Then, the various
steps to prepare the instrument for use will be described with
reference to FIGS. 24-34. Next, the use of stent applicator
instrument 400 will be described with reference to FIGS. 35-50.
Finally, steps will be described, as are shown in FIGS. 51-54, for
procedures where the instrument is to be re-used.
As shown in FIG. 6, stent applicator instrument 400 includes handle
portion 410 and endoscopic section 412. Endoscopic section 412 has
a distal end portion 414 which provides a carrying and placement
mechanism 416 adapted to place either male stent portion 221 or
female stent portion 223 in the end of a hollow organ to be
anastomosed. Handle portion 410 of stent applicator instrument 400
includes manual grip 418, a first trigger or first actuating means,
such as axle lever 420, a second trigger or second actuating means,
such as snap ring insertion lever 422, a knurled finger operative
dial such as tissue cutter dial 424 and a finger operative lever,
such as stent release toggle 426.
Referring temporarily to FIG. 16 in conjunction with FIG. 14, axle
lever 420 pivots toward manual grip 418 to first move axle holder
496 located at distal end portion 414 of the instrument, a short
distance, of approximately 1 mm to approximately 3 mm in a proximal
direction. With continued depression of axle lever 420 toward
manual grip 418, assembling means, such as axle holder 496 then
moves distally to force axle 216 or 218, loaded thereon, into stent
finger assembly 242 carried on support means, such as stent arbor
500 which is also located in distal end portion 414. Therefore, a
single complete depression of axle lever 420 towards manual grip
418 causes axle holder 496 to initially move in a proximal
direction, a short distance, and then to move in a distal
direction. Axle holder 496 and stent arbor 500 will be described in
further detail later in this section.
Referring once again to FIG. 6, snap ring insertion lever 422
pivots toward manual grip 418 to urge driving means, such as snap
ring tube 464 (FIG. 12) carrying snap ring 220 shown in FIG. 1, in
a distal direction. This locks the tissue of one end of the hollow
organ to be anastomosed in the stent finger assembly 242 with snap
ring 220. The use of the snap ring 220 eliminates the need for what
is conventionally known as "purse-string" sutures to close the ends
of the hollow organ prior to forming the anastomosis.
Tissue cutter dial 424 rotates clockwise to rotate tissue cutter
494 and to advance the tissue cutter 494 distally. Tissue cutter
dial 424 is further rotated clockwise to complete excision of
excess tissue around the newly inserted stent half portion. Stent
release toggle 426 pivots upward (shown in phantom) away from
handle portion 410 to release the inserted stent half portion from
stent applicator instrument 400. Each of these structural
components and their operation will now be described in detail.
B. THE HANDLE PORTION
In FIG. 7, handle portion 410 is shown in exploded perspective view
with one half-section of the cover removed for purposes of
illustrating various internal components. The purpose of handle
portion 410 is to provide controlled movement of carrying and
placement mechanism 416 (FIG. 6) at distal end portion 414. Manual
grip 418 includes split half-sections 428a and 428b (FIGS. 7, 8, 9,
10 and 21). The split half-sections comprise an outer housing for
handle portion 410 which is typically formed of a polycarbonate
material. Half-sections 428a and 428b may be attached by welding,
adhesives, etc.
Snap ring insertion lever 422 is pivotably mounted in the distal
end portion of manual grip 418. In a preferred embodiment, lockout
means are provided to prevent snap ring insertion lever 422 from
further movement once the lever has been pulled its full travel
distance thereby inserting the snap ring in position. Any suitable
lockout means may be utilized, such as, for example, spring loaded
pin 430 cooperating with receiving bore 430a formed in split
half-section 428a of handle portion 410. The lockout means helps
assure the user that the snap ring, once inserted, will not be
pulled out of the stent accidently.
Once fired, snap ring insertion lever 422 remains locked in place
for the completion of the procedure. If it is desired that the
instrument be reused, spring loaded pin 430 can be reset by
inserting an appropriately adapted pin or the like into the bore
formed in split half-section 428a, thereby freeing snap ring
insertion lever 422 to return to its initial position.
Alternatively, a reset button (not shown) or the like may be
permanently mounted in the receiving bore formed in split
half-section 428a. Snap ring insertion lever 422 is operatively
attached to an outer tube of endoscopic section 412 which is spring
loaded to bias the outer tube in a proximal direction as will be
described in further detail in the following section.
Axle lever 420 is pivotably mounted in handle portion 410 in
reverse pivotal cooperation with axle release lever 432, which is
also pivotably mounted in handle portion 410. Axle tube yoke 434 is
securely mounted to axle tube 436 such that upon depression of axle
lever 420, axle release lever 432 pivots such that a top portion
thereof moves toward the proximal end of stent applicator
instrument 400. Axle release lever 432 contacts axle tube yoke 434
and urges it toward the proximal end of stent applicator instrument
400 for a distance of approximately 1 mm to approximately 3 mm.
Then, upon further depression of axle lever 420, extended portion
438 of axle lever 420 contacts axle tube yoke 434 and urges it
distally. The function and purpose of this mechanism will be better
understood from the description presented in the section entitled
OPERATION.
Air fitting 440 is mounted in a recessed portion formed in handle
half sections 428a and 428b such that gas port 442 is in gaseous
communication with arbor tube 444 and gas port 446 (shown in FIG.
8). Gas port 446 is in gaseous communication with passageway 448
formed in handle half section 428a, as shown in FIG. 8. Passageway
448 in turn communicates with vacuum supply connector 450. Stent
release toggle 426 is operatively connected to push rod 452, which
is slidably disposed within arbor tube 444, which in turn is
slidably disposed within axle tube 436. These different components
and their functional relationships will be described in greater
detail in the following section. Tissue cutter dial 424 is
rotatably mounted to the proximal end of endoscopic section 412 and
its structural and functional relationships will also be discussed
in greater detail in the following section. Tissue cutter dial 424
extends from housing half sections 428a and 428b through cut-outs
formed therein, respectively.
FIGS. 9, 10 and 11 illustrate a lock-out feature for preventing
premature release of the stent from the stent arbor. The components
of lock-out mechanism 453 are best shown in the exploded partial
view of FIG. 9. Striker bar 454 is spring loaded and biased toward
axle tube yoke 434 such that striker bar 454 abuts axle tube yoke
434 when yoke 434 is in a prefired position. Cover plate 456 serves
to hold striker bar 454 in a recess formed in handle half section
428b. Striker bar 454 is operatively associated with pivoting
lock-out member 458 which is spring loaded in housing half section
428b such that extended barrier portion 460 is urged downwardly
away from extension member 462 (FIG. 21) of stent toggle release
lever 426. The lock-out prevents stent toggle lever 426 from being
raised to release the stent from the stent arbor unless axle tube
yoke 434 has been moved distally away from striker bar 454.
C. THE ENDOSCOPIC SECTION
Referring now to FIG. 12, endoscopic section 412 is shown in
exploded view, with parts separated, for convenience of
illustration and includes numerous concentric components which make
up several sub-assemblies for performing the various functions of
stent applicator instrument 400. The first of the sub-assemblies to
be described facilitates insertion of a tissue retaining member
such as snap ring 220 when snap ring insertion lever 422 is pulled
to its proximal-most position. Snap ring tube 464 is secured at a
proximal end to drive bushing 466 having drive yoke 468 securely
fastened thereto. Drive yoke 468 is operatively connected to snap
ring insertion lever 422 of handle portion 410 such that when snap
ring insertion lever 422 is pulled by the operator towards manual
grip 418, snap ring tube 464 is urged distally away from handle
portion 410. Spring 469, which rests on bearing 471, biases drive
bushing 466 and thus snap ring tube 464 toward the proximal end of
stent applicator instrument 400. Snap ring holder 470 is mounted at
the distal end of snap ring tube 464, as best illustrated in FIGS.
13 and 14.
In a preferred embodiment, snap ring holder 470 consists of a thin
wall tube having narrow fingers, such as fingers 471 shown in FIG.
14, cut in a distal end thereof. Fingers 471 have narrow lip 473
which mates with a groove formed in snap ring 220. The fingers are
designed to be normally flexed inward, i.e. in a disengaged
position with respect to snap ring 220. In a loaded position, the
fingers are biased outward by an object such as a cutter blade
which will be described in further detail later in this section. In
the loaded position the cutter blade or other object pushes out on
fingers 471 which engage and hold snap ring 220 in place on snap
ring holder 470. When it is desired to release snap ring 220, the
cutter blade or other biasing object is retracted so that is moves
behind snap ring holder 470 allowing the fingers to flex inward
thus releasing snap ring 220 from the distal end of snap ring tube
464.
Referring again to FIG. 12, a tissue cutting subassembly is shown
positioned within snap ring tube 464, which also serves as a
housing for endoscopic section 412. The tissue cutting sub-assembly
comprises drive shaft 472 secured at a proximal end to tissue
cutter dial 424 and secured to handle split half-sections 428a and
428b such that drive shaft 472 is fixed relative to handle portion
410. Drive shaft 472 is slidably connected to coupling member 474,
for example, by way of pins 476 frictionally fit in bores formed
near the proximal end of coupler member 474 sliding in
diametrically opposed slots 478 formed on the outer surface of
drive shaft 472. This causes the tissue cutting sub-assembly to
move along with snap ring tube 464 upon depression of snap ring
insertion lever 422.
At the distal end of coupling member 474, cutter cam 480 is mounted
in a similar fashion as drive shaft 472, i.e. pins 482 being
frictionally fit in bores formed near the distal end of coupling
member 474 and fitting within slots 484 formed on cutter cam 480
near a proximal end thereof. Spring 485 biases cutter cam 480
distally. Cam follower 486 is secured to snap ring tube 464 and
cooperates with cutter cam 480 by way of camming pin 488 fitting
into a cam track having two helical camming slots, shorter camming
slot 489 corresponding to a ready-for-use position and longer
camming slot 491 corresponding to a stored position. The operation
of these camming slots will be described in further detail in the
following section. Cutter cartridge 490 is slidably mounted within
the distal end of cutter cam 480 and is biased by spring 492
distally away from cutter cam 480. Cutter ring 494 is securely
mounted at the distal end of cutter cartridge 490.
Disposed within the tissue cutting assembly is an axle holder and
insertion sub-assembly wherein axle tube 436 has axle tube yoke 434
securely attached to a proximal end (FIG. 7) and axle holder 496
securely attached to a distal end. Axle holder 496 has fingers 497,
best shown in FIG. 14, fabricated to be normally in a collapsed
state. Protruding portions 499 (FIGS. 13 and 18) are disposed along
the inner surface of each finger 497 and are biased against arbor
tube 444 pushing fingers 497 radially outward. This structural
configuration provides for holding the appropriate axle member on
axle holder 496. When axle holder 496 is advanced distally,
protruding portions 499 fall into gap 501 (FIG. 14) formed between
the distal end of arbor tube 444 and stent arbor 500.
Vacuum holes 498 are formed through axle tube 436, adjacent to axle
holder 496, which is best illustrated in FIG. 14. Referring again
to FIG. 12, arbor tube 444 is positioned within axle tube 436 and
is securely mounted at the proximal end in air fitting 440 (FIG.
7). Stent arbor 500 is securely attached to a distal end of arbor
tube 444. vacuum holes 502 are formed near the distal end of arbor
tube 444 and are preferably aligned with vacuum holes 498 of axle
tube 436, as shown in cross-section in FIG. 15.
Slidably positioned within arbor tube 444 is push rod 452 which is
operatively connected to stent release toggle 426 (FIG. 7) at a
proximal end and has spreader member 504 attached to a distal end.
Spreader member 504 is adapted to spread open fingers 507 formed on
stent arbor 500 which are normally biased radially inward by
elastomeric ring 509.
D. OPERATION
The operation of the control members of stent applicator instrument
400 will now be described with reference to FIGS. 16-23.
Depression by the operator on axle lever 420 as shown in FIG. 16,
causes axle release lever 432 to pivot such that top portion 506
swings toward the distal portion of handle portion 410. Axle
release lever 432 thereby makes sliding contact with axle tube yoke
434 (FIG. 8) urging it in a proximal direction for a distance of
approximately 1 mm to approximately 3 mm. This motion initially
pulls axle tube 436 in a proximal direction and consequently axle
holder 496 and whichever axle member is mounted thereon, either
male axle 216 or female axle 218, also in a proximal direction.
Upon further depression of axle lever 420 axle release lever 432
loses contact with axle tube yoke 434 by passing into a void within
handle portion 410 formed by a cut-out on the axle tube yoke 434,
as illustrated by a phantom line on axle tube yoke 434 in FIG. 16
and designated 435 in FIG. 7. This cut-out can be varied to alter
the length of proximal travel of axle tube 436. After still further
depression of axle lever 420, upper portion 508 of axle lever 420
makes contact with axle tube yoke 434 along angled surface 437,
extending therefrom, thereby urging distally mounted axle holder
496 (FIG. 13) in a distal direction. Upon complete depression, axle
lever 420 remains in the fully depressed position due to the spring
biasing provided by spring 510.
Snap ring insertion lever 422 is squeezed by the operator, as shown
in FIG. 17, urging drive yoke 468 in a distal direction thereby
driving snap ring tube 464 into the stent assembly. Tissue cutter
dial 424 is rotated clockwise to advance cutter cartridge 490 and
cutter ring 494 distally into position to cut excess tissue away
from the anastomotic site, as shown in FIGS. 18 and 19. In an
alternative embodiment, tissue cutter dial 424 may be eliminated
and the excess tissue left remaining.
The operation of stent release toggle 426 is illustrated in FIGS. 9
and 20-23. Once axle tube yoke 434 is moved distally by axle lever
420, striker bar 454 is urged distally by spring 512 thereby
lowering pivotably mounting lock-out member 458 and providing
sufficient clearance for extension member 462 to pass without
contact therewith (FIG. 21). Stent release toggle 426 can then be
raised, as shown in FIG. 22, to move spreader 504 (FIG. 23)
distally away from stent arbor 500, thereby releasing the stent
assembly (not shown in FIG. 23) from stent arbor 500.
E. PREPARATION FOR USE
In FIGS. 24-34, several preparatory steps are illustrated which are
preferably performed immediately prior to beginning the surgical
procedure. In one preferred embodiment, stent applicator instrument
400 is configured such that minimal positioning of components is
necessary, when taken from any packaging which may be provided with
the instrument. For example, snap ring insertion lever 422 is
preset, i.e. in the pre-fired state, axle lever 420 is in the fully
depressed position (as shown in FIG. 16) with axle holder 496 in
the forward position, as shown in FIGS. 24 and 25. Cutter ring 494
is in the fully proximal or reset position (FIG. 13) with camming
pin 488 (FIG. 12) located in the closed end of longer helical
camming slot 491 provided on cutter cam 480, to allow for
retraction thereof, proximal of snap ring holder 470 (FIG. 13) and
within snap ring tube 464. Stent release toggle 426 is in the
raised or open position.
Although not critical, the preferred order of preparing stent
applicator instrument 400 for use involves the following steps.
Trocar adapter 505 is passed over distal end 414 of stent
applicator instrument 400 as shown in FIG. 24. Snap ring 220 is
inserted on snap ring holder 470 as shown in FIG. 25. Referring
temporarily to FIGS. 52-54, cutter ring 494 is advanced to its
distal-most position by rotating tissue cutter dial 424 (FIG. 1)
clockwise until cutter ring rotates without further distal travel
(not shown). From distal end 414 looking proximally, cutter ring
494 is then pulled distally, either by hand or with any suitable
grasping instrument and rotated counter-clockwise (facing blade
494a), approximately one-quarter turn, as shown in the progression
from FIG. 52 to FIG. 53, to switch the alignment of camming pin 488
from longer camming slot 491 (FIG. 12) where it was originally, to
align camming pin 488 with shorter camming slot 489 (FIG. 12).
Tissue cutter dial 424 is then rotated counterclockwise so that
shorter camming slot 489 receives camming pin 488 (FIG. 12). Upon
further counterclockwise rotation of tissue cutter dial 424, cutter
ring 494 comes to rest in its loaded position, which due to the
shorter length of helical camming slot 489 is at a more distal
location than the stored position such that cutter ring 494 pushes
radially outward on snap ring holder 470. In this position, cutter
ring 494 urges fingers 471 of snap ring holder 470 radially outward
to help hold snap ring 220 in place when same is loaded in
place.
Cutter ring 494 is now ready for use, such that upon clockwise
rotation of tissue cutter dial 424, cutter ring 494 rotates and
moves distally as camming pin 488 guides cutter cam 480 until
camming pin emerges from shorter camming slot 489 and enters
annular groove 493. Then, upon further clockwise rotation of tissue
cutter dial 424, cutter ring 494 rotates at a fixed position
relative to the distal end of stent applicator instrument 400.
Either male or female axle 216 or 218, respectively, is attached to
axle holder 496 (female axle 218 is shown in FIG. 26). The axle is
attached such that slots 280 formed along its inner surface, as
shown on female axle 218 in FIG. 27, are aligned with keys 503
formed on fingers 497 of axle holder 496, as shown in FIG. 28. The
mounted axle is then pushed proximally, as is indicated by arrow A
in FIG. 29, so that axle holder 496 and axle tube 436 move
proximally. This resets axle lever 420 to the position of FIG. 29
and retains either male axle 216 or female axle 218 (as shown in
FIG. 18) on axle holder 496. Retention occurs because, as axle
holder 496 moves proximally, protruding portions 499 (FIG. 13)
initially slide in gap 501 (FIG. 14) and with further proximal
movement then cam over the distal end of arbor tube 444. This urges
fingers 497 radially outward such that keys 503 bias against slots
495 thereby applying sufficient radial pressure to retain either
axle member on axle holder 496.
FIGS. 30-34 illustrate the steps of placing stent finger assembly
242 (FIG. 2A) on stent arbor 500. Subassembly 245 consists of stent
collapser body 244 containing stent finger assembly 242, already in
the collapsed position, as shown by FIG. 30 and described in the
section entitled PREPARATION OF THE STENT FINGER SUB-ASSEMBLIES.
Sub-assembly 245 is passed over distal end 414 of stent applicator
instrument 400, FIG. 31, such that keys 243 on distal end 211 of
stent finger assembly 242 align with channels 514 formed on distal
end 516 (FIG. 14) of fingers 507 of stent arbor 500, as shown in
FIG. 32. In this position, the collapsed inner stent fingers 222
will seat under the distal end 217 or 219 (FIG. 1) of either male
axle 216 or female axle 218, respectively, whichever is loaded on
axle holder 496. Stent finger assembly 242 will remain held in the
collapsed state, until the axle 216 or 218 is moved proximally to
release the inner stent fingers. The stent finger assembly remains
in the collapsed configuration until axle 216 or 218 is moved
proximally because (i) the axle 216 or 218 holds inner stent
fingers 222 and (ii) inner stent fingers 222 pull radially inward
on holding means, such as tabs 260 of outer stent fingers 214 (FIG.
5).
Stent finger assembly 242 is then locked on stent arbor 500. Stent
release toggle 426 is lowered pulling spreader 504 proximally
within the open end of stent arbor 500. Fingers 507, normally
biased radially inward by elastomeric ring 509, are urged radially
outward so that channels 514 of stent arbor 500 engage keys 243 of
inner stent finger member 212 to hold stent finger assembly 242 on
stent arbor 500, as shown in FIG. 32. Trocar adapter 505 is pushed
distally until it contacts and pushes stent collapser body 244 off
the distal end of stent applicator instrument 400, as shown in the
progression from FIG. 33 to FIG. 34. Thus, stent applicator
instrument 400 is now ready to apply one half-stent portion, i.e.
male stent portion 221 (FIG. 50) or female stent portion 223 (FIG.
50) containing either a male or female axle, respectively, to the
open end of one of the hollow sections to be joined.
F. USE OF STENT APPLICATOR INSTRUMENT
Stent applicator instrument 400 will now be described in use. FIGS.
35-42 show the various handle control portion positions at proximal
end 410 and the corresponding actions occurring at distal end 414
of instrument 400. FIGS. 43-50 show the actions occurring at the
distal end of instrument 400 when applying a stent half-portion to
one end of a hollow tissue section to be joined. Stent applicator
instrument 400 is first prepared for use as described in the above
sub-section bearing that title. It is then inserted into trocar
adapter 505 and then into the appropriate trocar, such as trocar
540, at the laparoscopic surgical site. At this point, distal end
414 of instrument 400 is preferably arranged as shown in FIG. 34,
with the handle portion appearing as illustrated in FIG. 35. Once
trocar adapter 505 reaches the proximal portion of trocar 540,
instrument 400 is further inserted so that trocar adapter 505
remains stationary and the stent finger assembly 242 as well as
axle 216 or 218 emerge therefrom, as shown in FIGS. 36 and 43.
Distal end 414 of stent applicator instrument 400 is then inserted
in the open end of one of hollow sections 10 to be joined, as shown
in FIG. 44. Preferably, endoscopic grasping instruments (not
shown), known in the art, are inserted down other cannulas already
in place and pull the open end 12 of the tissue over distal end 414
of instrument 400. Once the tissue is in position over vacuum holes
498, as shown in FIG. 45, axle lever 420 is squeezed to drive axle
218 (or 216) into stent finger assembly 242, as shown in FIGS. 37
and 38. As described in a previous section, upon squeezing axle
lever 420, axle holder 496 first moves proximally a short distance
of approximately 1 mm to approximately 3 mm, or any distance
sufficient to allow inner stent fingers 222 to be released from
axle 218 (or 216). Stent finger assembly 242 thereby expands and
inner fingers 222 spread open slightly. Then, upon further
squeezing of axle lever 420, axle holder 496 moves axle 218 (or
216) distally causing the axle to enter the proximal end of the
stent finger assembly 242. When axle lever 420 is fully depressed,
axle 218 (or 216) causes stent finger assembly 242 to expand to its
full diameter which is approximately 2-4 mm greater than that of
the cannula. Axle 218 (or 216) becomes latched in stent finger
assembly 242 (FIGS. 18 and 38) by way of latching means, such as
extended portions 218a and 218b of axle 218 (or extended portion
216a of axle 216, not shown) engaging locking means, such as
recessed portions 214a and 214b of outer stent fingers 214, as
shown in FIG. 18.
At this point, instead of tying a conventional "purse-string"
suture to hold end 12 of hollow organ section 10 within the
diameter of the compressional surfaces of the stent fingers (the
proximal end 213 of stent finger assembly 242, as shown in FIG.
2A), a vacuum source (not shown) is operatively connected to vacuum
supply connector 450 (FIG. 8). Any suitable vacuum source may be
used, such as commercially available units particularly adapted for
use in surgical procedures. When the vacuum is switched on, end 12
of the hollow organ 10 is sucked radially inward, as shown in FIG.
46. Intentional vacuum leaks may be provided in axle holder 496 and
stent arbor 500. These leaks allow the tissue to be pulled down
onto axle 218 (or 216) and stent finger assembly 242, as well as at
vacuum holes 498. By using the vacuum source to hold the end of the
hollow organ in place, much time and effort on the part of the
surgical team is saved.
The insertion of snap ring 220 will best be understood with
reference to FIGS. 39, 40 and temporarily back to FIG. 18. With the
vacuum source still turned on, snap ring insertion lever 422 (FIG.
39) is pulled to pass the snap ring holder 470 and snap ring 220
distally over end 12 of tissue held on vacuum holes 498 and 502. As
snap ring 220 moves distally over the tissue it forces the tissue
to fold over proximal end 213 (FIG. 2A) of stent finger assembly
242 by snap ring 220 and snap ring holder 470. As snap ring 220
continues to move distally it passes along camming surface 260
formed on the inside of outer stent fingers 214. This spreads the
Outer stent fingers sufficiently to allow snap ring 220 to enter
into annular groove 262 formed along the inner surface of outer
stent fingers 214. A portion of end 12 of tissue is thus retained
between snap ring 220 and the inner surface of annular groove 262.
The stent half-portion (consisting of the snap ring 220, stent
finger assembly 242 and axle 216 or 218) is now securely attached
to end 12 of the hollow tissue section.
Referring momentarily to FIGS. 18 and 19, once snap ring 220 is
securely in place, the vacuum supply is turned off. Tissue cutter
dial 444 (FIG. 6) is rotated clockwise for approximately three
turns such that blade 494a of cutter ring 494 separates excess
tissue from within the longitudinal through-passageway .(i.e.
lumen) of the stent half-portion. Tissue cutter dial 444 it is then
rotated counterclockwise causing the longer slot 491 of the two
helical camming slots 489, 491 to travel over camming pin 488 so
that cutter ring 494 returns to its proximal-most or stored
position.
The newly formed tissue stent half-portion complex is released from
stent applicator instrument 400 by raising stent release toggle
426, as shown in FIGS. 41, 42 and 49. The above procedure is then
repeated to insert the mating stent half-portion in the other end
section 12 of hollow organ 10 to be joined. Once completed the two
ends 12,12 are ready to be joined, as shown in FIG. 50. It is
within the scope of the present invention for the distal end of
stent applicator instrument 400 to be detachable from the handle
portion so that a second distal end, ready-to-use, may be at the
surgical site. However, stent applicator instrument 400 may be
re-usable for the same instrument to place both stent half-portions
in place. If the same instrument is used to place both stent
half-portions, then some steps must be taken to reset the
instrument and prepare it with the appropriate stent assembly
components as described in the following section.
G. PREPARATION FOR RE-USE
FIGS. 51-54 show the steps necessary to prepare stent applicator
instrument 400 for re-use. Snap ring insertion lever 422 is
released from the locked out position by inserting reset tool 514
into reset bore 516, as shown in FIG. 51, to compress the spring of
spring loaded pin 430 (FIG. 7). Once the spring is compressed, the
spring loading of snap ring tube 464 causes it to move proximally
thereby pivoting snap ring insertion lever 422 back to the
pre-fired position.
Cutter ring 494 is reset by rotating tissue cutter dial 424
clockwise until cutter ring 494 is fully extended, as shown in FIG.
52. This seats camming pin 488 in annular groove 493 of cutter cam
480 (FIG. 12). Facing the distal end of stent applicator instrument
400, cutter ring 494 is pulled distally and rotated clockwise
(facing the blade 494a and looking proximally) approximately 1/8 of
a turn, as shown in the progression from FIG. 52 to FIG. 53. This
transfers camming control from the longer helical camming slot 491
to the shorter helical camming slot 489 for allowing the cutter
ring to be placed in the snap ring holding position. The cutter
ring is retracted by rotating tissue cutter dial 424
counterclockwise until it stops, i.e. until camming pin 488 seats
in the closed end of shorter helical camming slot 489. The cutter
ring is at this point positioned just inside snap ring holder 470,
as shown in FIG. 54. Stent applicator instrument 400 is now ready
to be prepared for use according to the above section of the same
title.
IV. STENT ASSEMBLY CLOSING DEVICE
A. GENERAL
To join male stent portion 221 and female stent portion 223, a
unique closing device has been developed. The device is illustrated
in perspective view at FIG. 55 as stent assembly closing device
600. Although the following description will focus on application
of the instrument for joining male and female stent portions 221
and 223, respectively, clearly the instrument can be adapted for
use in approximating other surgical implant device components or
the like. Except where noted otherwise, the materials utilized in
the components of the device generally include such materials as
polycarbonate for housing sections and related components, and
stainless steel for such components which transmit forces. One
preferred polycarbonate material is LEXAN brand polycarbonate
available from General Electric Company. Other specific preferred
materials such as nylon or glass filled nylon (for strength) may
also be utilized. However, equivalent alternative materials will
readily come to the mind of those skilled in the art.
Stent assembly closing device 600 includes handle portion 610 and
endoscopic section 612 having at distal end portion 614
approximating means, such as wrist and finger mechanism 616.
Included in wrist and finger mechanism 616 are wrist 618 having a
first pair of grasping means, such as fingers 620, which are
pivotably operable between at least an open position and a closed
position, attached thereto. A second pair of grasping means, such
as fingers 622 are also provided which are also pivotably operable
between at least an open position and a closed position (FIGS.
63-65). In the closed position, fingers 620 and 622 are able to be
inserted through a cannula for access to the surgical site. In a
preferred embodiment at least one intermediate locking position is
provided so that fingers 620 and 622 may be locked in a
predetermined degree of closure position during usage of the
device.
Generally, wrist 618 will selectively pivot up to about 30.degree.
with respect to a longitudinal axis extending centrally through
endoscopic section 612. The pivoting of wrist 618 occurs about an
axis substantially perpendicular to the longitudinal axis of
endoscopic section 612. In the illustration of FIG. 55, wrist 618
and movable fingers 620 are shown in general alignment with the
central longitudinal axis of endoscopic section 612 and pivoted
outward as shown in phantom lines to illustrate a range of
movement.
B. THE HANDLE PORTION
Referring now to FIGS. 55-58, handle portion 610 of closure device
600 includes manual grip 624 and a pivotable trigger, such as wrist
lever 626, which is pivoted toward and away from manual grip 624.
Wrist lever 626 is pivoted away from manual grip 624 to move wrist
618 and fingers 620 away from fingers 622. Wrist lever 626 is moved
toward manual grip 624 to move wrist 618 and fingers 620 such that
fingers 620 are generally in line with the central longitudinal
axis of endoscopic section 612. The configuration of stent assembly
closing device 600 as shown in FIG. 55, i.e. with wrist 618 pivoted
such that fingers 620 are in line with the central longitudinal
axis of endoscopic section and fingers 620 and 622 are in the
closed position, facilitates insertion and removal of stent
assembly closing device 600 into or out from an appropriately sized
trocar cannula, respectively, so as to allow endoscopic access to
the surgical site.
Handle portion 610 is shown in exploded perspective view with parts
separated in FIG. 56 and includes an outer housing preferably
formed of separate sections 624a and 624b as shown, preferably of
polycarbonate material. The separate parts shown are preferably
attached by welding, adhesives, etc. The ultimate purpose of handle
portion 610 is to provide controlled operation, from the proximal
end, of the various functional members located at distal end 614 of
stent assembly closing device 600.
Wrist lever 626 is pivotably mounted in handle portion 610 and is
connected to wrist push rod 634 by pivotable mounting pin 636 being
slip fit into a bore formed on an upper portion of wrist lever 626.
Closure and opening of fingers 620 and fingers 622 at the distal
end is accomplished by rotation of first toggle 638 and second
toggle 640, respectively. First toggle 638 and second toggle 640
are provided with actuation levers 642 and 644, respectively, which
are readily activated by the thumb or index finger of the operator.
In order to provide space between actuation levers 642 and 644, a
block of filler material such as spacer member 646 (FIG. 62) is
provided between first toggle 638 and second toggle 640. In this
manner, the operator may independently operate either first toggle
638 or second toggle 640, thereby opening or closing movable
fingers 620 or movable fingers 622 independently.
The finger closure control sub-assembly, formed by first toggle
638, spacer member 646 and second toggle 640, each being rotatably
mounted on pin 648, is rotatably mounted in a cavity formed in the
proximal section of manual grip 624 by recesses molded into each of
split half-sections 624a and 624b. Pin 648 is friction fit into
bores formed in each split half-section 624a and 624b. When mounted
in manual grip 624, actuation levers 642 and 644 project outwardly
from manual grip 624 through an opening formed in the proximal end
thereof by a recessed portion cut into each of split half-sections
624a and 624b.
First toggle 638 and second toggle 640 are operatively connected to
first push rod 650 and second push rod 652, respectively. Any
suitable connecting means may be utilized. For example, as shown in
FIG. 58, threaded end portions 654 and 656 of push rods 650 and
652, respectively, are threaded into rod bearings 658 which are
slip fit in pivots 660. Retaining yokes 662 straddle pivots 660 and
extend downwardly therefrom from each of first toggle 638 and
second toggle 640. As shown in FIG. 56, each of the various push
rods, namely, wrist push rod 634 and finger push rods 650 and 652
extend into outer tube 660 of endoscopic section 612 through end
plug 662. The various push rods pass through endoscopic section 612
and emerge therefrom through bore holes formed in a flange portion
of end plug 664 (FIG. 59) disposed in the distal end portion of
outer tube 660 of endoscopic section 612.
C. THE ENDOSCOPIC SECTION
In the embodiment shown, endoscopic section 612 is intended to be
permanently attached to handle portion 610. FIG. 56 shows suitable
fastening means such as threaded bore holes 628 receiving screws
630 passing through bores 632 formed in split half-sections 624a
and 624b of manual grip 624. The device shown is contemplated to be
entirely disposable, although it is within the scope of the
invention to make the device reusable. For example, it is also
contemplated and considered to be within the scope of the invention
to construct the endoscopic section to be selectively detachable
whereby the handle portion may be sterilized and reused. In an
alternative embodiment, the wrist and finger mechanism can be made
selectively detachable and disposable so that the handle portion
and the remainder of the endoscopic section can be sterilized and
reused.
As shown in FIG. 59, first and second push rods 650 and 652 extend
through end plug 664 which is securely mounted in the distal end of
outer tube 660. First and second push rods 650 and 652 are
operatively connected to slide plates 666 and 668 respectively.
Fingers 620, 622 are distal of outer tube 660 and functionally
attached to end plug 664. Fingers 622 are pivotably attached to arm
670 by pins 673 and 675. Arm 670 is securely fastened to end plug
664. Slide plate 668 is operatively connected to fingers 622, such
as for example by slide plate 668 being mounted between cover
plates 676, 678 and 680 on one side and arm 670 on the other side.
Closure of fingers 622 is controlled by camming pins 672 and 674
sliding in camming slots 682 an 684, respectively. Camming slot 682
is preferably a straight diagonal camming slot which translates to
continuous closure of finger 622 which is operatively connected
thereto. Camming slot 684 is operatively connected to finger 622
and is configured to cause finger 622 to open or close for an
initial travel portion of camming pin 674 and camming slot 684 and
to remain in a fixed closure position for a remainder of the travel
of camming pin 674 in camming slot 684.
Sliding plate 666 is operatively connected to fingers 620 in the
same fashion as described for sliding plate 668. That is, sliding
plate 666 is mounted between cover plates 686, 688, 690, and 692
with camming pins 694 and 696 traveling in camming slots 698 and
700, respectively, to provide the same motion for fingers 620 as
described for fingers 622. However, fingers 620 are pivotably
mounted to wrist 618, which is pivotably connected to arm 704.
Wrist 618 is operatively connected to push rod 634 which upon
reciprocating motion causes wrist 618 to pivot with respect to arm
704 and thereby swings fingers 620 as much as about 30' toward and
away from the central longitudinal axis of stent assembly closing
device 600.
D. OPERATION OF THE CLOSING DEVICE
Operation of the fingers and wrist of stent assembly closing device
600 will now be described with reference to FIGS. 60-67. When stent
assembly closing device 600 is inserted into a cannula placed in an
incision at the surgical site, fingers 620 and 622 are in their
fully closed position as shown in FIG. 63. To position the fingers
in the fully closed configuration, first and second toggles 638 and
640 are urged to the position illustrated in FIG. 57. Once stent
assembly closing device 600 has been inserted into the surgical
site, first and second toggles 638 and 640 may then be urged to the
position corresponding open position as shown for fingers 622 in
FIG. 64. In this position the fingers are open wider than the
diameter of the respective stent-tissue complex so that the
stent-tissue complex may be placed within the open fingers.
When it is desired to grip and join the respective stent-tissue
complexes, toggles 638 and 640 are urged from the fully open
position as shown in FIG. 60, to the clamped position as shown in
FIG. 61. With the toggles in the configuration of FIG. 61, fingers
620 and 622 are positioned as shown in FIG. 65 for finger 622. In
this position, fingers 622 and 620 are closed about the
stent-tissue complexes. To prevent fingers 620 and 622 from opening
when the stent-tissue complexes are joined, spacer member 646 is
preferably provided with positioning means. The positioning means
may include rounded depressions, i.e. detents 706 and 708, and
springs 710 disposed within chambers 712 and 714 formed in each of
the toggles 638 and 640, respectively. Each spring 710 is biased
against a ball bearing 716, or the like, which seats in the
respective rounded depression 706 formed on each side of spacer
member 646.
As shown in FIG. 66, to operate wrist 618, wrist lever 626 is
pivoted away from manual grip 624 driving wrist push rod 634
distally which causes wrist 618 to pivot outwardly from arm 704
into an open position. To close wrist 618, wrist lever 626 is
pivoted toward manual grip 624 thereby pulling wrist push rod 634
in a proximal direction and causing wrist 618 to pivot inwardly
towards the central longitudinal axis of stent assembly closing
device 600 until finger 620 are positioned as shown in phantom
lines in FIG. 67.
E. USE OF THE CLOSING DEVICE
In use, once the stent-tissue complexes have been formed by stent
applicator instrument 400, stent assembly closing device 600 is
inserted down through the cannula and fingers 620 and 622 are
opened to their fully opened position by moving toggles 638 and
640. The stent tissue complexes are then placed within the opened
fingers and the stent toggles urged to their clamped position as
shown in FIG. 61, thereby locking fingers 620 and 622 about the end
portions of the stent-tissue complexes as shown in FIG. 68. Once
the fingers are in a clamped position, wrist lever 626 is pivoted
toward manual grip 624 bringing the two ends of the opposing
stent-tissue complexes together as shown in FIG. 69 and 70. In FIG.
70 locking means such as male axle 216 is shown mated with locking
means such as female axle 218 as the wrist is urged to the closed
position thereby completing the anastomosis.
V. THE KIT
The present invention is readily adaptable to be provided to
surgeons in the form of a kit in which all necessary equipment and
accessories are provided in sterile form ready for use in surgery.
For example, the stent applicator instrument 440, the trocar
adapter and the stent assembly closing device 600 of the present
invention can be readily packaged with a supply of stent assembly
components sufficient to assemble at least one male and female
stent half-portion. The different instruments and components may be
provided separately, as a matched kit or in a blister or other type
package, suitable and ready for use by the surgeon and the
surgeon's assistants. The instruments and stent components can be
provided in any size matched to meet the needs of the particular
anastomosis to be performed.
In addition, the kit can include a matching trocar assembly (not
shown) with appropriate valve assembly to prevent loss of the
insufflating gas from the peritoneum between the trocar and the
outside surface of the endoscopic section. The outer housing of the
endoscopic section is substantially closed at the point of
attachment of either the stent holding and placing assembly on the
stent applicator instrument and the wrist and finger mechanism of
the stent closing device. Thus, release of insufflating gases
through these distal end mechanisms and the endoscopic section
housing is either non-existent or minimal. Such a trocar assembly
is available from United States Surgical Corporation, Norwalk,
Conn., under the trademark SURGIPORT brand trocar assembly. See
also U.S. Pat. No. 5,116,353 to Green which is hereby incorporated
herein by reference.
While the invention has been particularly shown and described with
reference to the preferred embodiments, it will be understood by
those skilled in the art that various modifications in form and
detail may be made therein without departing from the scope and
spirit of the invention. Accordingly, modifications such as those
suggested above, but not limited thereto, are to be considered
within the scope of the invention.
* * * * *